Release agent receptacle

ABSTRACT

The present disclosure includes method, system, apparatus, and indicator embodiments. One apparatus includes an appliance for placement over one or more teeth and a release agent receptacle including an outer portion provided on appliance surface, an inner portion provided within the outer portion, and one or more apertures formed in the outer portion.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/863,059, filed Sep. 23, 2015, which is a continuation ofU.S. patent application Ser. No. 14/558,418, filed Dec. 2, 2014, nowU.S. Pat. No. 9,730,769 on Aug. 15, 2017, which is a continuation ofU.S. patent application Ser. No. 12/011,942, filed Jan. 29, 2008, nowU.S. Pat. No. 8,899,976 on Dec. 2, 2014, which is a continuation in part(CIP) of U.S. patent application Ser. No. 11/799,979, filed May 3, 2007,now U.S. Pat. No. 7,854,609, which was a continuation in part (CIP) ofU.S. patent application Ser. No. 10/949,717, filed on Sep. 24, 2004, nowU.S. Pat. No. 7,553,157, the disclosure of which is incorporated in itsentirety herein by reference.

BACKGROUND

The present disclosure is related to systems and methods for providingrelease agent receptacles.

As noted in commonly owned U.S. Pat. No. 6,607,382 entitled “Methods andsystems for concurrent tooth repositioning and substance delivery,” thecontent of which is incorporated herewith, the repositioning of teethmay be accomplished with the use of a series of removable elasticpositioning appliances such as the Invisalign® system available fromAlign Technology, Inc., the assignee of the present disclosure. Suchappliances have a thin shell of elastic material that generally conformsto a patient's teeth but is slightly out of alignment with an initial orimmediately prior tooth configuration. Placement of the elasticpositioner over the teeth applies controlled forces in specificlocations to gradually move the teeth into the new configuration.Repetition of this process with successive appliances including newconfigurations eventually moves the teeth through a series ofintermediate configurations or alignment patterns to a final desiredconfiguration. A full description of an exemplary elastic polymericpositioning appliance is described in U.S. Pat. No. 5,975,893, and inpublished PCT application WO 98/58596, the content of these documentsare incorporated by reference for all purposes.

The appliance is effective in repositioning teeth when it is placed overthe patient's teeth. In some implementations, it is desirable to wearthese appliances most of the day (e.g., all of the time except wheneating and maintaining oral hygiene, such as by brushing or flossing).Although easy and convenient to wear, the patient may not wear theappliance as prescribed by the treatment professional. Extended removalof the appliance, for any reason beyond what is recommended, interruptsthe treatment plan and lengthens the overall period of treatment. Sincethe appliance is removable by the patient, the treatment professionalhas to rely on the patient to comply with the prescription.

Additionally, there may be many variables and differences in eachpatient's oral environment and, therefore, one type of complianceindicator may not likely be enough to last for a desired period of wearin every person. Some examples of the factors that may change the wearrate include an amount of saliva produced, one or more tooth anatomiesor locations, a composition of saliva, an analysis of sleep habits of apatient, an amount of liquid consumption, and one or more types ofliquid consumed, among other criteria. These factors can make theanalysis of compliance based upon a wear indicator difficult due to thedifferent wear rates that different people may have.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an exemplary compliance indicator.

FIGS. 2A-2C show a first embodiment of the compliance indicator of FIG.1.

FIGS. 3A-3B show a second embodiment of the compliance indicator of FIG.1.

FIGS. 4A-4B show a third embodiment of the compliance indicator.

FIG. 5 shows a fourth embodiment of the compliance indicator.

FIG. 6 shows a fifth embodiment of the compliance indicator.

FIG. 7 shows a sixth embodiment of the compliance indicator.

FIG. 8 shows a seventh embodiment of the compliance indicator.

FIG. 9 shows an eighth embodiment of the compliance indicator.

FIG. 10 shows an appliance having a release agent receptacle accordingto an embodiment of the prevent disclosure.

FIG. 11 shows a cut-away side perspective view of the receptacleembodiment of FIG. 10.

SUMMARY

The present disclosure includes method, system, apparatus, and indicatorembodiments. One apparatus includes an appliance for placement over oneor more teeth and a release agent receptacle including an outer portionprovided on appliance surface, an inner portion provided within theouter portion, and one or more apertures formed in the outer portion.

Another apparatus embodiment includes an apparatus for monitoringorthodontic treatment compliance includes an appliance adapted to beworn over one or more teeth; and a compliance indicator mounted on theappliance or teeth to indicate compliance. Advantages of someembodiments of the system include one or more of the following. Somesuch apparatus embodiments provide better data for communicating devicecompliance with patients, including: increased patient knowledge andrecall of appliance usage; increased compliance in wearing the dentalappliance, and increased patient satisfaction as a result. The apparatusprovides a channel of self-monitoring for the patient. The apparatusalso reduces patient's anxiety levels without requiring verbal orwritten instructions since device usage is self-evident. The treatmentprofessional also has better information on patient progress during thetreatment.

DESCRIPTION

FIG. 1 shows an exemplary removable appliance 15 adapted to fit overteeth on a jaw 16. A usage indicator 100 can be mounted on one tooth oron the appliance 15 to indicate patient compliance.

In one implementation, the indicator 100 can be a coat on a tooth or anappliance with a chemical agent. Alternatively, the indicator 100 can bean electrical agent, optical agent or mechanical agent that indicatesappliance wearage. In some embodiments, the indicator agent is inactiveuntil contact with liquid or moisture. Alternatively, release of theagent can be stimulated by liquid or moisture. Thus, in one case, uponwearing, oral fluids activates the agent and allows the agent to seepout and indicate compliance. Alternatively, oral fluids such as saliva,among others, can seep in to activate the agent to indicate compliance.

In another embodiment, the appliance can release a coloring agent to theoral environment when the appliance is worn over the teeth. Suchmechanisms may include a layer which includes the agent. The layer maybe formed over at least a portion of the surfaces of the repositioningappliance. These surfaces include both the cavity surfaces, the surfaceswithin the cavities which contact the teeth when in place, and theexternal surfaces, the surfaces of the appliance which contact thecheeks and lips when in place. The layer may be of various materials andmay take a variety of forms. For example, the layer may consistessentially of the agent. In other words, the agent may be attacheddirectly to a surface of the polymer shell of an elastic repositioningappliance. This may be achieved by applying the agent (optionally in aninert carrier or diluent) itself to the surface utilizing a number ofmethods, such as spraying, painting and/or dipping. When therepositioning appliance is placed over the patient's teeth, the agentmay then be released to the oral environment.

Alternatively, the layer may include the agent present in or on acarrier or binder which promotes adhesion or attachment to the applianceand/or which creates a matrix from which the agent can be released bydiffusion or dissolution. In some embodiments, the agent is dissolved inthe carrier or binder. In this case, the agent may be provided in powderor similar form and dissolved in a liquid solvent. The result may be asolution which may be applied to a surface of the shell, typically byspraying, painting, and/or dipping, to form a coating or film. When therepositioning appliance is placed over the patient's teeth, thecompliance indicating agent may then be released from the coating to theoral environment. Release may be due to activation or deactivation ofthe carrier or any other releasing mechanism, such as by enzymes orproteins in oral fluids. Or release may be due to degradation of thecarrier by contact with, for example, oral fluids. In some cases, thebinder or carrier may evaporate upon application to the layer to thesurface leaving the agent behind. In these cases, the agent may bereleased in a similar fashion as when the agent is directly attached tothe surface, as described above. It may be appreciated that any suitableagent, such as fluoride materials, antibiotics or other drugs ormedications, vitamins, bleaching materials, and/or breath fresheners,may be delivered to the oral environment in this manner.

In another embodiment, the agent is encapsulated or suspended in thelayer. A common material for suspension of an agent is a semisolidmaterial, such as a gel, jelly, or putty. Such a material may be appliedto a surface of the shell by spraying, painting, and/or dipping to forma coating or film. Here, as in all cases, suspension is not limited to ascientific definition and may refer to any situation in which a carrierholds, contains, supports, or otherwise includes an agent. Alternativelyor in addition, the semisolid material may be deposited in the cavitiesof the polymer shell which are shaped to receive the teeth. The cavitiesmay be filled to any desired level. When the repositioning appliance ispositioned over the teeth, the teeth will directly contact the semisolidmaterial in the cavities and displace any extra material as the teethare inserted into the cavities. Therefore, it is desired to fill thecavities to a level which will avoid excess overflow of the materialfrom the appliance. Delivery of an agent by use of a semisolidsuspension material is common in bleaching treatments and fluoridetreatments, for example. However, such treatments apply the materialwith the use of a tray or generic appliance which does not applyrepositioning forces to the teeth. By modifying a repositioningappliance, as described above, orthodontic treatment may continuethroughout the delivery of such agents. It may be appreciated that anyagent, particularly fluoride materials, antibiotics, bleachingmaterials, and breath fresheners, may be delivered to the oralenvironment in this manner.

Another common material for encapsulation or suspension of an agent is acontrolled-release material. Thus, the layer may be of arate-controlling material wherein the rate controlling material controlsthe rate at which the agent is released from the layer.Controlled-release or rate-controlled materials deliver a predeterminedamount of an agent at a predetermined rate. Often such deliverymaintains a steady-state concentration of an agent in an environmentwithin a desired therapeutic range for a prolonged period of time. Thus,a prescribed dosage may be delivered. In addition, the ability tosustain delivery eliminates the need for repeated applications of theagent for dosed delivery to the oral environment.

Although such controlled release materials may be provided as asemisolid material, such as a gel, jelly, or putty, as described above,these materials may also be provided as a solid material which isattached to the polymeric shell of the repositioning appliance. One typeof controlled-release material includes a polymer matrix membrane withinwhich finely dispersed particles of an agent are suspended. The agentmay diffuse through the matrix membrane according to a concentrationgradient. Alternatively or in addition, the agent may be released bydegradation of the polymer matrix membrane material. In either case, thecontrolled-release material may be provided as a sheet which may belaminated to a surface of the shell. The controlled-release sheet may belayered with the elastomeric polymer and vacuum formed over a mold toform the repositioning appliance. The controlled-release material may bearranged so that it is present on the inside or outside surfaces of theappliance depending on the material and desired application. Or, thecontrolled-release sheet may be laminated or bonded to a surface of thepolymeric shell after forming to supply agent delivery in desired areas.Alternatively, the controlled-release material may be provided as atablet or similar mass which may be inserted into the polymeric shell ofthe repositioning appliance. The agent may then elute from the tabletinto the oral environment over time.

In another embodiment, the agent may be held within pores of a materialand may elute out at a controlled rate from the pores. The agent itselfmay be absorbed into the pores of the material, or the agent may besuspended in a carrier which is absorbed into the pores of the material.In the latter case, the agent may be released from the carrier bydiffusion and/or by controlled degradation of the carrier material. Thismay incorporate a rate-controlling mechanism in addition to thecontrolled-release of the agent from the pores. As mentioned, in somecases, enzymes in the patient's oral fluids will activate the release ordegrade the carrier material to release the agent. It may be appreciatedthat the agent may be released by a combination of any of the releasemethods.

In a further embodiment, the polymeric shell of the repositioningappliance itself includes a controlled-release material containing theagent. In this case, at least a portion of a polymeric shell is formedfrom a controlled release material wherein the rate controlling materialcontrols the rate at which the agent is released from the shell. Aspreviously described, the controlled-release material may be a providedin the form of a sheet. Thus, the sheet of controlled-release materialmay be vacuum formed over a mold of the patient's teeth to form arepositioning appliance itself. In this manner, no additionalelastomeric materials may be needed to form the appliance. Thecontrolled-release material may be a polymer matrix membrane, a porousmaterial, or any suitable material. Controlled-release may be designedso that the elution rate of the agent corresponds to the repositioningrate of the teeth. The agent may elute throughout the repositioningprocess, concluding as the teeth reach the desired arrangementprescribed by the appliance.

In a still further embodiment, the releasing mechanism coupled to atleast some of the repositioning appliances includes a reservoir formedin the shell of the appliance in addition to the cavity which receivesthe teeth. Typically, a rate controlling membrane is disposed over thereservoir wherein the rate controlling membrane controls the rate atwhich the substance is released from the reservoir. The reservoir may bepre-filled or pre-loaded with an agent or substance for delivery. Inthis case, the appliance may be ready for insertion or use upon removalfrom any packaging without the need of loading the appliance with theagent for delivery. If the releasing mechanism is designed for a singledelivery period, the appliance may be worn throughout the prescribedrepositioning period and then disposed of. If the releasing mechanism isdesigned for multiple delivery periods, the reservoir may be replenishedwith the agent to be released any number of times throughout theprescribed repositioning period. It may be appreciated that any agent,particularly fluoride materials, antibiotics, bleaching materials, andbreath fresheners, may be delivered to the oral environment in thismanner.

In some instances, it may be desirable to change a visual characteristicof the polymeric shell of an oral appliance. Such appliances include apolymeric shell having a cavity shaped to be removably placeable overthe teeth and a material on or within the shell that changes a visualcharacteristic of the shell. Such a change is typically in response to achange in the environment. In some cases, the visual characteristic is acolor, such as green, red, or blue. Thus, the appliance may appearcolored or a particular color under certain environmental conditions,either in the oral environment or when removed. The described materialmay be a dye which changes color in response to a change in temperature.For example, the dye may change color when the appliance is removed fromthe mouth and changes temperature from body temperature (37 degree C.)to room temperature (25 degree C.). Similarly, the dye may change colorwhen the appliance is rinsed with cool water.

The appliance can be used to provide an intra-oral drug delivery system.In addition to the agents described above, other compounds can be usedas well. For example, a drug coated appliance can be used to deliverdesensitizing medication to sensitive teeth. The drug substance cansimply be a small amount of the active ingredient in a desensitizingtoothpaste or gel, such as Sensodyne®. The desensitizing agent isdispersed throughout the surface of the appliance and is delivered, at asubstantially constant rate, to the patient's sensitive teeth for arelatively extended period of time.

Although the appliance may be pre-loaded with the agent and ready foruse upon removal from any packaging, appliances that are not pre-filledor pre-loaded may require loading prior or immediately prior to placingthe appliance over the teeth. Loading may include placing the agent in ateeth-receiving cavity. As described previously, the cavities may befilled to any desired level. When the appliance is positioned over theteeth, the teeth will directly contact the agent in the cavities as theteeth are inserted into the cavities. Alternatively, loading may includeplacing the agent into an agent release reservoir in the applianceimmediately prior to placing the appliance over the teeth. The agentwill then elute from the reservoir into the oral environment when theappliance is in place over the teeth. The elution rate may be controlledby a controlled release membrane which separates the reservoir from thesurrounding environment. Loading may also include adhering a ratecontrolling material containing the agent to a surface of the applianceprior to placing the appliance over the teeth. Such a material mayinclude a polymer matrix membrane which may be removably or permanentlyadhered to the polymeric shell of the appliance in desired areas fordelivery of the agent. And finally, loading may include absorbing theagent into a porous material on or within the appliance immediatelyprior to placing the appliance over the teeth.

Mechanisms for releasing the agent may include a number of embodiments,including any such mechanisms previously described. Typically,mechanisms for releasing the agent includes a layer including the agent,as previously described, and coupling includes adhering the layer to atleast a portion of a surface of the appliance. When the layer consistsessentially of the agent, adhering may involve coating, spraying,dipping, or painting the agent on the surface of the appliance. Thus, apre-formed appliance may simply be coated with the agent prior toinsertion in the patient's mouth. When the layer includes an agentpresent in or on a carrier or binder, adhering may involve attaching thecarrier or binder a surface of the appliance. Similarly, when the agentis encapsulated in the layer, the layer may be attached to the surfaceof the appliance. The layer may include a sheet of rate controllingmaterial wherein the rate controlling material controls the rate atwhich the agent is released from the layer. In this case, the sheet maybe bonded to the surface of the appliance with an adhesive.Alternatively, the sheet may be attached to the surface by pressfitting. The sheet and the surface may each be shaped so that they snapor fit together by pressing them together. For example, the sheet mayhave a formed protrusion and the surface a formed inset, wherein theprotrusion fits into the inset when pressed upon the inset and holds thesheet in place. In many instances, the appliance may be porous or have areservoir which can be loaded with a desired agent at any time thetreating professional and/or the patient decide that it is appropriate.For example, an appliance can be immersed in a solution of the agent,allowing the appliance to absorb or adsorb the agent at a particulartime.

In addition, the sheet may be pre-formed to a shape adapted for fittingagainst the surface of the appliance or a surface of the teeth orgingiva. For example, the sheet may be pre-formed to reflect the shapeof the surface of one or more teeth or the gingiva, particularly alongthe gingival margin. The preformed sheet may then be held against thatsurface when the sheet is coupled to the appliance and the appliance isplaced over the teeth. Coupling may involve any mechanism of attachingthe sheet to the appliance. In particular, the pre-formed sheet mayfurther include an adhesive layer which may provide bonding of the sheetto the surface of the appliance.

The material to make to the appliance of FIG. 1 can be supplemented withadditional fillers such as electrically conducting fillers, magneticfillers, illuminating fillers, piezoelectric fillers, and/or lightsensitive fillers. The material properties of the appliance made with orwithout these additional fillers such as modulus, electrical resistance,material permeability, and birefringence (degree of orientation of thematerial or stress), illuminating patterns or patterns under speciallight sources may change after the appliance is worn over time, as theseproperties are altered due to changes in structure, organization, and/orspatial spacing between the fillers. For example, it is well establishedthat electrical conductivity of filled composites scales with fillervolume concentration according to percolation theory. Therefore,mechanical deformation or thermal expansion of the non-conductivepolymer matrix will lead to increased average inter-filler spacing, ordecreased filler volume concentration, and consequently decreasedelectrical conductivity. Examples of electrically conductive fillersinclude metals, graphite, electrically conductive polymers,semiconductors, and superconductors. These changes in properties can beused as an indicator for compliance and can be diagnosed byinstrumentation. Similarly, separation of conductive fillers will alsolower thermal conductivity, which can also be measured byinstrumentations. If the fillers have magnetic behavior in the presenceof external stimulation, such as diamagnetics (Cu, Au, Ag, etc.) andparamagnetics (e.g. Al, Cr, Na, Ti, Zr, etc.); or exhibit intrinsicmagnetic properties, such as ferromagnetics (Fe, Co, Ni, etc.),antiferromagnetics (e.g. MnO), and ferromagnetics (MFe.sub.2O.sub.4),then separation of the filler spacing due to mechanical deformation ofthe polymer matrix can also lead to decreases in magnetic propertiesabove the Curie temperature. Mechanical deformation of composites withilluminating fillers, such as those that exhibit luminescence,fluorescence, or phosphorescence, will result in decreased illuminationintensity. Bending deformation or displacement of piezoelectric fiberscan result in electrical potentials which can be either measured, orused to activate other electrically driven indicators (e.g. low powerLED light). Fillers with optical properties which depend on externalelectric field, for example those that shift their absorptioncoefficients in the UV, IR, or visible spectrum can also serve asindicator of matrix deformation.

Referring now to FIG. 2A, an embodiment of an indication attachmentdevice 200 is shown. The indication attachment device 200 includes apolymer well 201, and the well 201 includes a semi-permeable membrane202. The membrane 202 allows a two-way flow between the well 201 and aninterface to the oral environment. Within the well 201, a material 204such as a dyed material is provided.

In some embodiments, the dyed material 204 is a releasable material,such as dyed poly(vinylsiloxane) (PVS) material. The PVS material isused to hold the dye, and the membrane 202 can be a cellulose acetatemembrane. Those skilled in the art will understand that other releasablematerials such as polyether, polyurethane, ethyl vinyl acetate can alsobe manipulated to result in the teachings of this patent.

In another embodiment, the well material 204 can be an enzyme or areactor that reacts with enzymes from the oral fluids. When oral fluidsor enzyme from the oral fluids enters the well, the material 204 reactswith the enzyme to provide an indication. Alternatively, a pH indicatorcan be used as the material 204. In yet another embodiment, the membrane202 can be silicon instead of PVS.

In another embodiment, the polymer can be water-soluble polymer thatincludes water-soluble polymers, lightly cross-linked hydrogels, andhigh molecular weight with hydrogen bonding plastics that demonstratesome limited water resistance. Natural-based water-soluble polymersinclude starch, starch-oxided, cellulose, cellulose-alkoxylated,cellulose-carboxyalkylated, chitin, chitosan, pectins, hyaluronic acid,proteins, and lignin. Water-soluble polymers can also be created fromsynthetic raw material through polymerization by addition/vinyl,condensation, and ring-opening. Examples of these types of polymers arepoly(vinyl alcohol), polyesters, and poly(alkylene oxides). Thehydrolytic instability of biodegradable polymers is advantageous becausethe presence of the oral fluids will facilitate the degradation of thepolymer.

Referring now to FIG. 2B, a cross-sectional view of the complianceindication attachment device (compliance indicator) 200 is shown. Asviewed therein, the membrane 202 is positioned above the polymer well,chamber, or housing 201 with the releasable material and or dye 204enclosed therein. As shown in FIG. 2C, after a predetermined period oftime, for example two weeks, a portion of the dyed PVS material 204 hasseeped out causing a change in appearance of the indication attachmentdevice. The dye is released while the PVS stays inside the device. Inthis case, a color change can occur or alternatively, the volume of thematerial has changed, in this case it has reduced in size.

In some embodiments, the compliance indicator 200 has a clear,tooth-colored, or esthetically pleasing polymer reservoir well, chamber,or housing 201. A transparent or translucent semi-permeable membrane 202separates the content within the reservoir chamber 201 from the externaloral environment. The content(s) within the reservoir chamber 201depends on the overall strategy to monitor compliance. In oneimplementation, contents diffuse out from the reservoir chamber 201,through the membrane 202, into the external environment. For example:the content can be an FDA approved visible dye which diffuses from thechamber 201, through the membrane 202, and into the external oralenvironment. When the content is emptied, the content color diminishesin brightness and value. Colorants that are permitted for directaddition to human food by the US FDA include annatto extract,beta-carotene, beet powder, canthaxanthin, caramel color, carrot oil,cochineal extract (carmine); cottonseed flour, fruit juice, paprika,riboflavin, saffron, turmeric, vegetable juice, FD&C Blue No. 1(brilliant blue) and No. 2 (indigotine), FD&C Green No. 3 (fast greenFCF), FD&C Red No. 3 (erythrosine) and No. 40 (allura red), FD&C YellowNo. 5 (tartrazine) and No. 6 (sunset yellow). Other food colorants suchas those found at FDA's Center for Food Safety and Applied Nutritionwebsite: http://www.cfsan.fda.gov/.about.dms/col-toc.html can be used aswell.

In another implementation, matter from the external environment diffusein, and reacts with the contents 204 within the reservoir chamber 201.For example, glucose molecules from the external environment diffusethrough the membrane 202, and reacts with enzymes inside the content andthe resultant enzymatic products interact with other reactants insidethe content to cause color change. As more glucose molecules diffuse in,content color increases in brightness and value. A convenient enzymesystem is glucose oxidase and horseradish peroxidase. The first enzyme,glucose oxidase, catalyzes the oxidation of glucose to form gluconicacid and hydrogen peroxide. Hydrogen peroxide then reacts with3-3,5,5′-tetramethylbenzidine (TMB) under catalytic action ofhorseradish peroxidase to convert yellow TMB to green. Other colorants,such as potassium iodide (green to brown) may also be used. Theseenzymes can be immobilized within the chamber. The rate of reaction, andhence color change, can be controlled by selecting the permeability ofthe membrane 202, the concentration of reactants inside the chamber 201,and the method of delivery. The rate of reaction or concentration of theglucose molecules can also be detected through spectroscopy or otheranalytical testing. Test results will correlate with compliance totreatment.

Referring now to FIGS. 3A and 3B, another embodiment of an indicationattachment device is shown. In the embodiment of FIG. 3A, a porouspolymer material is provided on a sheet 300. The polymer material isdisposed on the sheet 300 as one or more containers 304. The container304 may be a well as disclosed above in the discussion of FIGS. 2A-2C.After a predetermined period of usage, the polymer material changesappearance, for instance, changes either to the color or the size asshown in FIGS. 2B-2C. Other implementations can include colored polymers(both thermoplastic and thermoset materials) and composites utilizingthe same compliance mechanism as the porous polymer material.

The compliance indicator of FIGS. 3A-3B thus can be a dye encapsulatedin a polymer which is released in the presence of oral fluids. The dyecan be colorants that react with the oral fluids and that are releasedfrom the polymer. The polymer can be porous polymer such as monolithicporous polymer (currently used in chromatography), PVS, a high internalphase emulsion (HIPE polymer currently used in drug release), or anymacroporous polymer. The dyed polymer will be constructed into a smallbutton that can be bonded to the exterior of the aligner. The amount ofdye loss will correspond with the amount of time the aligner was in use.The pore size of the polymer and the particle size of the dye willaffect the rate of diffusion of dye from the button to the oral fluidsenvironment and depending on compliance needs, these factors can becontrolled.

Porous polymers are prepared by adding “porogens” during thepolymerization process of resins. Porogens are soluble in the monomerbut insoluble in formed polymers. As polymerization occurs, pores areformed in the spaces where porogens are found. The newest type of porouspolymers is known as “high internal phase emulsions” (“HIPE”). HIPEstructures have pore diameters much larger than previous porousmaterials which had only pore diameters in the angstroms.

Another porous polymer is the monolithic porous polymer currently beingused in chromatography. The polymerization of this rigid macroporouspolymer takes the shape of the mold, usually a column, into which themonomers and porogens are poured into. Generally, the pore volume isnearly equal to the amount of porogens added into the monoliths.

Referring now to FIGS. 4A and 4B, a button embodiment of an indicationattachment device 400 is shown. In this embodiment, a biodegradablepolymer material is attached to either a tooth or a dental appliance.After a certain period of use, the polymer material either changes shapeor size or color, and as shown in FIG. 4B, the volume of thebiodegradable polymer material is subsequently reduced. In someembodiments, the button is a biodegradable polymer button. The buttoncan be molded from a biodegradable polymer and bonded to the exterior ofthe aligner. The button will have a predetermined degradation periodsuch as a two week degradation period in the constant presence of oralfluids. Potentially the polymer can be colored for a more visibleindication of the degradation of the button. The size and material willdetermine the degradation period of the button. However, other factorssuch as brushing of the aligner and rinsing will have to be taken intoconsideration when determining the optimal degradation time of thebutton.

The degradation products often define the biocompatibility of a polymer.Synthetic biodegradable polymers are favored over natural ones becauseof reliability of raw materials. The following is a list of commonbiodegradable polymers: polyglycolide (PGA), polylactide (PLA),1-lactide (LPLA), poly(dl-lactide) (DLPLA), poly(.epsilon.-caprolactone)(PCL), polydioxanone (PDO), poly(glycolide-co-trimethylene carbonate)(PGA-TMC), and polyorthoesters.

FIG. 5 shows yet another embodiment of an indication attachment device.In this embodiment, an appliance 416 receives an adhesive dye matrix412. The matrix 412 is sealed either at one end or both ends using abacking film 410. The material in the matrix 412 can be released on thesides between the appliance 416 and the film 410 or between the twobacking films. An opening 418 may be provided in the appliance 416 andone side of the backing film to facilitate dye release. In oneimplementation, a transdermal patch may be applied in a manner similarto drug releasing transdermal patches. Instead of embedding andreleasing drug in the adhesive matrix, a dye is released and themechanism for dye loss is moisture (oral fluids). In one implementation,appliance wear compliance is indicated by the color of the adhesivelayer: the more dye lost, the longer the wear time.

FIG. 6 shows yet another embodiment where the wear indication isachieved through a water dissolvable film. In this embodiment, an opaquewater soluble film 420 is positioned to cover one or more colored areas,regions, spots, or dots 422 on an appliance or on a tooth. The film canbe a protective coating that can be used to protect the indicator (e.g.,dot) from wear, such as from brushing teeth, etc. Since these appliancesmay be intended to be used for most of the day (e.g., 20+ hours), inmany situations, protection of the indicator may be helpful indetermining compliance.

In some embodiments, the protective coating can be removable and can beused to protect the indicators before and/or during application to anappliance or to one or more teeth. Such embodiments can also improve theaccuracy of compliance analysis, in some instances.

In some embodiments, the dots 422 can be a series of colored dots withvarying thicknesses of film 420 and each exposed color corresponds to adifferent amount of appliance wear time. In the embodiment where thedots 422 are imprinted on the appliance, the film 420 is layered ontothe surface of the appliance. The mechanism of releasing dye is moisture(oral fluids).

FIG. 7 shows another embodiment where a tooth attachment 444A is madewith a dye-releasing composite. The dye-releasing composite 444A bondedto a tooth will be covered by an appliance 416. Over time, thedye-releasing composite 444A has a reduced or no color loss compared tothe loss for a dye on an uncovered tooth attachment 444B. The color ofthe attachment will correspond to the amount of aligner wear. Themechanism of dye releasing is moisture (oral fluids) in this embodiment.

In yet other implementations, a diagnostic indicator can be provided.The diagnostic indicator is similar in device construction to thecompliance indicator, and utilizes the inwards diffusion strategy, wherebiochemical analytes from the external environment are allowed todiffuse through the membrane to react with the contents within thereservoir chamber. Thus, biomarkers from the external environmentdiffuse through the membrane, and react with reagents inside the contentto directly or indirectly induce color change or chemical change thatcan be quantified through human eye or laboratory testing orcomputerized vision systems. As more biomarkers diffuse into thediagnostic indicator, the content color changes, for example increasesin brightness and value. Possible biomarkers include enzymes, pH,glucose, salt, oral film, plaque, microorganisms that may exist in theoral cavity and amount of oral fluids.

In the embodiment shown in FIG. 8, the compliance indicator can be atime temperature indicator 480. The indicator 480 is intra-orally placedin the mouth (either directly on a tooth or on an appliance 470) andprovides an indication of the time the indicator has been at apreselected intra-oral temperature environment.

In yet another embodiment shown in FIG. 9, a plurality of brushes 502having a colored fiber 504 is positioned on the appliance 500. As thebrush 502 is gradually eroded by wearing the appliance 500, a dye, orother suitable indicia of wear in the fiber 504 is exposed for visualdetection by a human or by a machine. Alternatively, the brushes 502 canbe placed on one or more teeth instead of on the appliance 500.

In yet another embodiment, the compliance indication is human readableby changing physical or mechanical or visual properties that are readilyobservable by a human. In other embodiment, the compliance indication ismachine readable. For instance, in one embodiment that alters theelectrical characteristics of an appliance during wearing of theappliance, an electrical measurement can be made by a computer fordetecting compliance. In another embodiment that uses biomarkers, acomputer with biomarker sensor can be used with suitable computerprogram to detect compliance. In yet another embodiment, a color changecan be detected by a computer vision program to detect compliance.

Each computer program is tangibly stored in a machine-readable storagemedia or device (e.g., program memory or magnetic disk) readable by ageneral or special purpose programmable computer, for configuring andcontrolling operation of a computer when the storage media or device isread by the computer to perform the procedures described herein. Theinventive system may also be considered to be embodied in acomputer-readable storage medium, configured with a computer program,where the storage medium so configured causes a computer to operate in aspecific and predefined manner to perform the functions describedherein.

Portions of the system and corresponding detailed description arepresented in terms of software, or algorithms and symbolicrepresentations of operations on data bits within a computer memory.These descriptions and representations are the ones by which those ofordinary skill in the art effectively convey the substance of their workto others of ordinary skill in the art. An algorithm, as the term isused here, and as it is used generally, is conceived to be aself-consistent sequence of steps leading to a desired result. The stepsare those requiring physical manipulations of physical quantities.Usually, though not necessarily, these quantities take the form ofoptical, electrical, or magnetic signals capable of being stored,transferred, combined, compared, and otherwise manipulated. It hasproven convenient at times, principally for reasons of common usage, torefer to these signals as bits, values, elements, symbols, characters,terms, numbers, or the like.

It should be borne in mind, however, that all of these and similar termsare to be associated with the appropriate physical quantities and aremerely convenient labels applied to these quantities. Unlessspecifically stated otherwise, or as is apparent from the discussion,terms such as “processing” or “computing” or “calculating” or“determining” or “displaying” or the like, refer to the action andprocesses of a computer system, or similar electronic computing device,that manipulates and transforms data represented as physical, electronicquantities within the computer system's registers and memories intoother data similarly represented as physical quantities within thecomputer system memories or registers or other such information storage,transmission, or display devices.

FIG. 10 shows an appliance having a release agent receptacle accordingto an embodiment of the prevent disclosure. FIG. 10 illustrates that arelease agent receptacle can be provided (e.g., placed on, manufacturedon) on an appliance 1015 such as an aligner for dental treatment, amongother types of dental appliances.

In the embodiment of FIG. 10, the release agent receptacle includes anouter portion 1050 provided on appliance surface 1048, with an innerportion 1052 provided within the outer portion 1050, and an aperture1054. In some embodiments, the inner portion 1052 can be encapsulatedwithin the outer portion 1050.

In various embodiments, an outer portion can, for example, be providedby a polymer and/or curable material (e.g., ultra violet-curableacrylic) among other types of suitable materials. Other examples ofsuitable materials include, but are not limited to materials such as anultra violet-acrylic material, an epoxy material, a urethane material, arubber material, an ethylene vinyl acetate material, an elastomermaterial, a plastic material, and/or a silicone material, among othersuitable material types.

The inner portion 1052 can be utilized as an active portion of therelease agent receptacle, wherein the inner portion has an activeingredient such as a dye, pigment, or other indicator material and/ormaterials that can be used for treatment. In such embodiments, thesereceptacles can be referred to as compliance indicators so long as theyhave the functionality of compliance indication.

In some embodiments, the active ingredient can be embedded in a polymeror other suitable type of material. Polymers and other such materialscan be useful in such embodiments, for example, because the rate atwhich the active ingredient is released or leaches out may be controlledby the type of polymer or other such material the active ingredient isembedded in.

In order to facilitate the release of the material in the inner portionof the release agent receptacle, one or more apertures 1054 can beprovided through the outer portion 1050 and to the surface of the innerportion 1052. In some embodiments, the aperture 1054 can be providedthrough the outer portion 1050, through some or all of the inner portion1052 and/or into or through the outer portion 1050 that is proximate tothe surface 1048 of the appliance 1015. In various embodiments, the sizeand/or shape of the one or more apertures can be adjusted to change theamount, speed, direction, and/or other characteristics of the release ofthe material from the inner portion 1052.

The one or more apertures can be formed in any suitable manner. Forexample, in some embodiments, the aperture can be drilled through thecured adhesive to allow moisture, more specifically saliva, to interactwith an active ingredient in the inner portion. In some embodiments, theaperture can be formed during the formation of the other portions of theappliance (e.g., in some embodiments where the appliance and releaseagent receptacle are formed integrally).

The active ingredient can be any suitable ingredient for use in oralindication, diagnosis, and/or treatment and can be released in anysuitable manner. For example, in some embodiments, the mechanism ofdissolution of the active material and release can be through moisturefrom the mouth of the patient. A suitable example of an activeingredient is FD&C blue dye in the case of the compliance indicator,however, such and example should not be viewed as limiting on theembodiments of the present disclosure.

In some embodiments, as illustrated in FIG. 11, the release agentreceptacle can be formed with or integrally bonded to the surface of theappliance. In some embodiments, the release agent receptacle can beadhered to or non-integrally bonded to the surface of the appliance.

In such embodiments, a bonding material can be utilized that can, forexample, be composed of a biocompatible pressure-sensitive adhesive(e.g., acrylic, silicone, and/or polyisobutene) which can allow foradhesion of the release agent receptacle to the aligner surface, orother suitable surfaces.

In some embodiments, the compliance indicator can be a wear indicator.As discussed herein, use of various materials can be utilized to providea number of different wear rates. A wear material can, for example, becomposed of a water-soluble polymer (e.g., high molecular weightpolyvinyl alcohol) mixed with a FD&C (FDA certified) “aluminum lakes”dye which allows for leaching of the color over a period of time, amongother materials

Although the wear rates of these indicators may not be standardized fromone patient to another, the wear rates of these indicators can bepredetermined with respect to each other. In such embodiments,indicators of various wear rates with respect to each other can beutilized.

Such wear indicators can be used as compliance indicators or astreatment disbursement apparatuses (e.g., for the disbursement of agentsas described herein) as the wearable material wears during use of theappliance to which it is associated. This wear can, for example beproduced through interaction with moisture as discussed above.

Such wear rates can be established, for example, by exposing the wearindicator to a uniform reactant (e.g., a material that causes theindicator to change). The periods of change to the indicators can bemeasured and can, therefore, be used to set the amount of expectedchange with respect to the other indicators similarly tested.

For instance, a dye may have a particular wear pattern over time, whichmay be uniform or may increase, decrease, or otherwise change over time.Such rates can be determined and the usage of the appliance calculatedbased upon where the wear indication provided by the indicator is on thewear pattern of the particular material being used in the indicator.

Some examples of the type of wear that can be used to determine the wearrate of the wear layer can determined based upon one of the factorsselected from the group including amount of saliva produced, one or moretooth anatomies or locations, a composition of saliva, an analysis ofsleep habits of a patient, an amount of liquid consumption, and one ormore types of liquid consumed, among other criteria. The analysis ofcompliance can be accomplished in any suitable manner based upon theinformation provided by the initial indicators.

FIG. 11 shows a cut-away side perspective view of the release agentreceptacle embodiment of FIG. 10. In the embodiment of FIG. 11, therelease agent receptacle includes an outer portion 1150 provided onappliance surface 1148, with an inner portion 1152 provided within theouter portion 1150, and an aperture 1154. In some embodiments, the innerportion 1152 can be encapsulated within the outer portion 1150 with theaperture being formed after the encapsulation has been done.

In some embodiments, the appliance 1148 can include one or more of therelease agent receptacles mounted on the appliance 1148 to indicatecompliance and/or the amount of treatment disbursement that has beendone by demonstrating a change in at least one characteristic of therelease agent receptacle. The changed characteristic can, for example,be a color, shape, and/or size, among others. In some embodiments,compliance and/or disbursement can be indicated by an absence of achange.

In order to facilitate the release of the material in the inner portionof the release agent receptacle, one or more apertures 1154, asdiscussed above, can be provided through the outer portion 1150 and tothe surface of the inner portion 1152. In some embodiments, the aperture1154 can be provided through the outer portion 1150, through some or allof the inner portion 1152, and/or into or through the outer portion 1150that is proximate to the surface 1148 of the appliance 1115.

Some embodiments may also continue the aperture through a portion or allof the thickness of the appliance. Such embodiments may allow formaterial from the inner portion 1152 to interact with the teeth and/orgingiva of the patient that are positioned on or near the aperture 1154within the appliance 1115. In various embodiments, the size and/or shapeof the one or more apertures can be adjusted to change the amount,speed, direction, and/or other characteristics of the release of thematerial from the inner portion 1152.

Although specific embodiments have been illustrated and describedherein, those of ordinary skill in the art will appreciate that anyarrangement calculated to achieve the same techniques can be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments of thedisclosure.

It is to be understood that the use of the terms “a”, “an”, “one ormore”, “a number of”, or “at least one” are all to be interpreted asmeaning one or more of an item is present. Additionally, it is to beunderstood that the above description has been made in an illustrativefashion, and not a restrictive one. Combination of the aboveembodiments, and other embodiments not specifically described hereinwill be apparent to those of skill in the art upon reviewing the abovedescription.

The scope of the various embodiments of the disclosure includes anyother applications in which the above structures and methods are used.Therefore, the scope of various embodiments of the disclosure should bedetermined with reference to the appended claims, along with the fullrange of equivalents to which such claims are entitled.

In the foregoing Detailed Description, various features are groupedtogether in a single embodiment for the purpose of streamlining thedisclosure. This method of disclosure is not to be interpreted asreflecting an intention that the embodiments of the disclosure requiremore features than are expressly recited in each claim.

Rather, as the following claims reflect, inventive subject matter liesin less than all features of a single disclosed embodiment. Thus, thefollowing claims are hereby incorporated into the Detailed Description,with each claim standing on its own as a separate embodiment.

The terms and expressions which have been employed in the foregoingspecification are used therein as terms of description and not oflimitation, and there is no intention, in the use of such terms andexpressions, of excluding equivalents of the features shown anddescribed or portions thereof, it being recognized that the scope of theinvention is defined and limited only by the claims which follow. Forexample, although films or appliances have been disclosed as mechanismsfor compliance measurement, droplets can be used to deliver thecompliance indicating substances to the patient as well.

Other embodiments for compliance indication can be used as well. Whereasparticular embodiments of the present invention have been describedherein for purposes of illustration, it will be evident to those skilledin the art that numerous variations of the details may be made withoutdeparting from the invention as defined in the appended claims.

We claim:
 1. A usage indicator for indicating patient compliance,comprising: a coating with an agent that is inactive until it comes incontact with liquid or moisture, wherein the agent is one of: a chemicalagent, an electrical agent, an optical agent, or a mechanical agent. 2.The usage indicator of claim 1, wherein the indicator is on a removableappliance, adapted to fit over teeth on a jaw.
 3. The usage indicator ofclaim 1, wherein release of the agent is stimulated by liquid ormoisture and wherein, upon wearing the appliance, oral fluids activatethe agent and allow the agent to seep out and indicate compliance. 4.The usage indicator of claim 1, wherein one or more oral fluids can seepin to activate the agent to indicate compliance.
 5. The usage indicatorof claim 1, wherein the agent is included in a layer, wherein the layeris formed over at least a portion of the surface of a repositioningappliance.
 6. The usage indicator of claim 5, wherein the layer consistsessentially of the agent, wherein the agent is attached directly to asurface of a polymer shell of the appliance, which is an elasticrepositioning appliance.
 7. The usage indicator of claim 5, wherein thelayer includes the agent present in or on a carrier or binder whichpromotes adhesion or attachment to the appliance and/or which creates amatrix from which the agent can be released by diffusion or dissolution,wherein the agent is dissolved in the carrier or binder, wherein theagent is provided in powder and dissolved in a liquid solvent, whereinthe solution may be applied to a surface of the appliance.
 8. A systemfor monitoring orthodontic treatment comprising: a first appliance forplacement over one or more teeth; and multiple wear indicators includingat least a first positional indicator having a wear rate and a secondpositional indicator having a wear rate, where the wear indicatorsinclude a coating with an agent that is inactive until it comes incontact with liquid or moisture, wherein the agent is one of: a chemicalagent, an electrical agent, an optical agent, or a mechanical agent, andwhere the wear rates of the first and second positional indicators arethe same and where the first positional indicator is placed in aposition on the first appliance that is different from the secondpositional indicator.
 9. A dental wear indicator, comprising: anadhesive layer: a wear indicator layer having a predetermined wear rate;and a protective layer.
 10. The dental wear indicator of claim 9, wherethe wear indicator layer includes an agent that is inactive until itcomes in contact with liquid or moisture, wherein the agent is one of: achemical agent, an electrical agent, an optical agent, or a mechanicalagent.
 11. The dental wear indicator of claim 9, where the protectivelayer is removable.
 12. The dental wear indicator of claim 9, where thedental wear indicator can demonstrate a change in at least onecharacteristic of the indicator, wherein the changed characteristiccomprises at least one of color, shape, deformation, and size.
 13. Thedental wear indicator of claim 9, where the change is affected by atleast one of moisture, temperature, one or more chemicals, or one ormore biological substances.
 14. The dental wear indicator of claim 9,where the dental wear indicator is adapted to be mounted onto a dentalappliance to indicate wear of the dental appliance.
 15. The dental wearindicator according to claim 9, wherein the dental wear indicator isadapted to alter the electrical characteristics of an appliance to whichit is applied.
 16. The dental wear indicator of claim 9, where a type ofwear that determines the wear rate of the wear indicator layer isdetermined based upon one of the factors selected from the groupincluding: an amount of saliva produced; one or more tooth anatomies orlocations; a comparison of saliva; an analysis of sleep habits of apatient; an amount of liquid consumption; and one or more types ofliquid consumed.
 17. A system for monitoring orthodontic treatment,comprising: a first appliance for placement over one or more teeth; andmultiple wear indicators including at least a first positional indicatorhaving a wear rate and a second positional indicator having a wear rate,where each wear indicator include a wear indicator layer having apredetermined wear rate, and where the wear rates of the first andsecond positional indicators are the same and where the first positionalindicator is placed in a position on the first appliance that isdifferent from the second positional indicator.
 18. The system of claim17, where each wear indicator include a wear indicator layer having apredetermined wear rate and a protective layer.
 19. The system of claim17, where each wear indicator includes an adhesive layer and a wearindicator layer having a predetermined wear rate.
 20. The system ofclaim 17, where each wear indicator includes an adhesive layer, a wearindicator layer having a predetermined wear rate, and a protectivelayer.